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Safety and Efficacy Evaluation of Erbium Treatment

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ClinicalTrials.gov Identifier: NCT00766376
Recruitment Status : Unknown
Verified January 2010 by Palomar Medical Technologies, Inc..
Recruitment status was:  Active, not recruiting
First Posted : October 3, 2008
Results First Posted : January 29, 2010
Last Update Posted : January 29, 2010
Sponsor:
Information provided by:
Palomar Medical Technologies, Inc.

Brief Summary:
The purpose of this research study is to evaluate the safety and effectiveness of erbium lasers for dermatological cosmetic procedures.

Condition or disease Intervention/treatment Phase
Skin Aging Device: Erbium laser Not Applicable

Detailed Description:

The purpose of this investigation is to evaluate erbium laser devices for dermatological cosmetic procedures.

Each subject will undergo up to 6 treatment sessions, with scheduled time-points for follow-up visits. The Investigator determines the number of treatments. Subjects may be treated on there face, neck, chest or other body areas as deemed appropriate by the Investigator. At each visit, the treated areas will be clinically evaluated for side effects and will also have photographs taken of their treated areas. Subjects will be asked to complete a self-assessment questionnaire at different time points throughout their study participation.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 151 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy Evaluation of Fractional Erbium Treatment
Study Start Date : July 2007
Estimated Primary Completion Date : July 2009
Estimated Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Erbium
U.S. FDA Resources


Intervention Details:
    Device: Erbium laser
    Erbium laser treatment. Each subject will undergo up to 6 treatment sessions


Primary Outcome Measures :
  1. Number of Participants That Scored Above a One Category (Mild) Improvement Using the Fitzpatrick Wrinkle Scale. [ Time Frame: participants at three months ]

Secondary Outcome Measures :
  1. Number of Participants That Have Reduction in Pigmented Lesions and Dyschromia. [ Time Frame: participants at three months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Healthy male and female Adults (18 years or older).
  • Subjects who can read, understand, and sign the Informed Consent Form.
  • Subjects willing and able to comply with all study requirements.

Exclusion Criteria:

  • Subjects with active localized or systemic infections.
  • Immunocompromised subjects.
  • Subjects with coagulation disorder.
  • History of skin photo sensitivity disorders, or use of photosensitizing drugs (e.g., tetracycline or sulfa drugs).
  • Pregnant and/or lactating (All female volunteers will be advised about using birth control during the period of study).
  • In the opinion of the trained clinician, subject is unwilling or unable to adhere to all study requirements, including application and follow-up visits.
  • Use of Accutane® within the past 6 months.
  • Subjects with a history of radiation therapy to the treatment area.
  • Subjects with any skin pathology or condition that could interfere with evaluation or with the use of typical ancillary medical treatments or care used before, during or after treatments.
  • Subjects have undergone dermatological procedures (e.g., laser or light treatments) for the treatment of wrinkles, skin resurfacing, or skin rejuvenation in the treatment area within 1 year of study participation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00766376


Locations
United States, California
Scripps Clinic Laser & Cosmetic Dermatology
San Diego, California, United States, 92130
United States, Massachusetts
Palomar Medical Technologies, Inc.
Burlington, Massachusetts, United States, 01803
Brooke Seckel, MD
Concord, Massachusetts, United States, 01742
United States, New Hampshire
Skin & Laser Surgery Center
Nashua, New Hampshire, United States, 03060
United States, Texas
The University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75390
Sponsors and Collaborators
Palomar Medical Technologies, Inc.

Responsible Party: Medical Director, Palomar Medical Technologies, Inc.
ClinicalTrials.gov Identifier: NCT00766376     History of Changes
Other Study ID Numbers: ERf-02
First Posted: October 3, 2008    Key Record Dates
Results First Posted: January 29, 2010
Last Update Posted: January 29, 2010
Last Verified: January 2010